MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WORKMATE¿ CLARIS¿ SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H700123
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the amplifier was unable to turn and the case was cancelled.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One claris¿ amplifier was received for evaluation.Power was applied to the amplifier and the amplifier power switch would not come on, which duplicates the reported symptom.The right fuse was not functional for the power input module from an undetermined event.The left fuse still shows a resistance and was not compromised.The reported event was able to be duplicated by power sequencing and internal inspection.Based on the investigation and information provided to abbott, the reported event was confirmed, and the root cause was attributed to physical/electrical damage to one of the input fuses from an undetermined event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.¿.

• Brand Name: WORKMATE¿ CLARIS¿ SYSTEM
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13338780
• Report Number: 2184149-2022-00019
• Device Sequence Number: 4064384
• Product Code: DQK
• UDI-Device Identifier: 05415067001238
• UDI-Public: 05415067001238
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K151911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H700123
• Device Catalogue Number: H700123
• Device Lot Number: 5350315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown